A Study in Chinese Patients With Acquired Blepharoptosis

NCT06683651 | Recruiting Phase 3 DMC

• 1 other identifier: 101380002CN
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 21

Brief Summary

This is a Phase III Study to evaluate the efficacy and safety of STN1013800 Ophthalmic Solution in Chinese Patients with Acquired Blepharoptosis. At present, there are no medicines for the treatment of acquired blepharoptosis in China. Therefore, to evaluate the efficacy and safety of 0.1% STN1013800 ophthalmic solution, Vehicle (Placebo) are designed. For the screening period, 3-7 days were set to confirm the subjects and judge their qualification. Dosage and administration were based on prior clinical trial results approved at 0.1% once daily for 42 days treatment.

Conditions

Blepharoptosis

Outcome Measures

Primary Outcomes (1)

• Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group

  Mean change from Baseline (Day 1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group in number of points seen in the top 4 rows on the Leicester Peripheral Field Test (LPFT test) at 2 time points

  Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)

Secondary Outcomes (2)

• Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group

  Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)

• Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group

  Day 1 at Minute 5, Minute 15, Hour 2; Day 14 at Minute 5, Minute 15, Hour 6; Day 42 at Minute 5, Minute 15

Study Arms (2)

STN1013800 ophthalmic solution

EXPERIMENTAL

0.1% STN1013800 ophthalmic solution administered once daily

Drug: STN1013800 ophthalmic solution

STN1013800 ophthalmic solution Liquid Base, without STN1013800

PLACEBO COMPARATOR

STN1013800 ophthalmic solution Liquid Base, without STN1013800 administered once daily

Drug: STN1013800 ophthalmic solution Liquid Base, without STN1013800

Interventions

STN1013800 ophthalmic solution DRUG

Investigational Product: 0.1% STN1013800 ophthalmic solution

STN1013800 ophthalmic solution

STN1013800 ophthalmic solution Liquid Base, without STN1013800 DRUG

Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800

STN1013800 ophthalmic solution Liquid Base, without STN1013800

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one eye diagnosed with acquired blepharoptosis and presence of all the following criteria at screening:
• Loss of reliable Leicester Peripheral Field Test (LPFT) of ≥ 8 points in the top 2 rows (LPFT Eligibility Score); subjects had to see at least 9 total points in the top 4 rows (LPFT Total Score).
• This criterion had to be met in both the Visit 1 Hour 0 (V1H0) and Visit 1 Hour 6 (V1H6) LPFT assessments.
• There had to be ≤4 points of variance between the V1H0 and the V1H6 LPFT Eligibility Score.
• The Marginal Reflex Distance-1 (MRD-1), the distance from the pupil center to the margin of upper lid, ≤ 2 mm (no visible pupil center defaults to 0) in the same eye
• Visual acuity is 0.25 decimals (i.e., Snellen 20/80) or better according to standard logarithmic visual acuity chart in the same eye
• Presence of all the following criteria at baseline:
• Loss of reliable LPFT of ≥8 points in the top 2 rows (LPFT Eligibility Score) in the same eye; subjects had to see at least 9 total points in the top 4 rows (LPFT Total Score).
• This criterion had to be met in the Visit 2 Hour 0 (V2H0) LPFT assessment
• There had to be ≤4 points of variance between the V1H6 and the V2H0 LPFT Eligibility Score;
• The MRD-1, the distance from the pupil center to the margin of upper lid, ≤ 2 mm (no visible pupil center defaults to 0) in the same eye
• Visual acuity is 0.25 decimals (i.e., Snellen 20/80) or better according to standard logarithmic visual acuity chart in the same eye
• Female subjects are 1-year postmenopausal, surgically sterilized, or females of childbearing potential (females who had started their menstrual cycles) with a negative urine pregnancy test at screening. Females of childbearing potential had to use an acceptable form of contraception throughout the study.

You may not qualify if:

• Dermatochalasis that extended less than 3 mm above the upper eyelid margin.
• Pseudoptosis (upper eyelid dermatochalasis that overhung the upper eyelid margin).
• In either eye: Congenital ptosis; Horner syndrome; Marcus Gunn jaw-winking syndrome; Myasthenia gravis.
• Mechanical ptosis, including ptosis due to orbital or lid tumour, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
• Previous ptosis surgery (previous blepharoplasty \[only\] was allowed provided the surgery took place \> 3 months prior to screening).
• Lid position affected by lid or conjunctival scarring; Visual field loss from any cause other than ptosis; History of herpes keratitis.
• History of closed/narrow angle glaucoma (unless patent peripheral iridotomy had been performed \> 3 months prior to screening).
• Periocular neurotoxin (e.g., Botox®, Dysport®) injections within 3 months prior to screening and during the study.
• Topical application of bimatoprost (i.e., Latisse®) to the eyelashes within 7 days prior to screening and during the study.
• Use of topical ophthalmic medications including but not limited to anti-allergy \[e.g., antihistamines like Emadine®, Patanol®\], dry eye \[e.g., Diquas®, Beifushu®; except artificial tears like Hyaluronate\], antimicrobial drugs \[e.g., antibiotics and antivirals like Cravit®,Tobrex®, Aciclovir\], and anti-inflammatory drugs
• Current punctal plugs or placement of punctal plugs during the study.
• Current use of over-the-counter (OTC) vasoconstrictor/decongestant eye medication or any ophthalmic or non-ophthalmic α-adrenergic agonist including OTC products at any time during the study.

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (21)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Shantou, Guangdong, China

NOT YET RECRUITING

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

NOT YET RECRUITING

The first affiliated hospital of Zhengzhou University

Zhengzhou, He'nan, China

RECRUITING

The 2nd Affiliated Hospital of Harbin Medical University

Ha’erbin, Helongjiang, China

NOT YET RECRUITING

Wuhan Aier Eye Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, China

NOT YET RECRUITING

The second norman bethune hospital of Jilin University

Changchun, Jilin, China

NOT YET RECRUITING

Dalian No.3 Peple's Hospital

Dali, Liaoning, China

NOT YET RECRUITING

The 4TH People's Hospital of Shenyang

Shenyang, Liaoning, China

NOT YET RECRUITING

Shandong Eye Hospital

Jinan, Shandong, China

RECRUITING

Eye & Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Shanxi Eye Hospital

Taiyuan, Shanxi, China

NOT YET RECRUITING

Panzhihua Hospital of Integrated Chinese and Western Medicine

Panzhihua, Sichuan, China

RECRUITING

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Eye Hospital, Wenzhou Medical University / Zhejiang Eye Hospital

Wenzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Central Study Contacts

Santen Pharmaceuticals Co., Ltd Clinical Operations

CONTACT

+81-6-4802-9341; clinical@santen.co.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CN (21)